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New treatment option for Breast Cancer
Official title Intelligent Vacuum Assisted Biopsy Immediately Before Surgery As an Intra- or Pre-Operative Surrogate for Patient Response to Neoadjuvant Chemotherapy for Breast Cancer
ClinicalTrials.gov ID: NCT04289935
What this study is testing
- What it's testing
- Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor)...
- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0
- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy
- Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or...
You likely can't join if
- Metastatic breast cancer
- Multifocal/Multicentric breast cancer
- Inflammatory breast cancer
- Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk if assessed by a validated...
- Distinct radiological sign of residual disease in the breast after neo-adjuvant chemotherapy by imaging
- Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis
See the full eligibility criteria
- Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
- unifocal, histologically confirmed invasive breast cancer with IHC luminal B (with or without overexpression or amplification of the HER2 receptor) and all ER negative (ER \< 10%) breast cancers
- Initial tumor size larger than 1 and less than 5 cm (cT1c to cT2), any N, M0
- Clipping of the primary tumor center prior to the start of neo-adjuvant chemotherapy
- Neo-adjuvant chemotherapy resulting in a radiological complete response or near complete response on MR-Imaging (confirmed within 28 days before or on registration) as described in the trial specific MR-Imaging...
- Former tumor bed must be accessible for biopsy
- Female or male aged ≥ 18 years
- Adequate condition for breast cancer surgery
- Patients with a previously treated malignancy are eligible, when the risk of the prior malignancy interfering with either safety or how well it works endpoints is very low
- Metastatic breast cancer
- Multifocal/Multicentric breast cancer
- Inflammatory breast cancer
- Luminal-A types of breast cancers (ER ≥ 10% and PgR ≥ 10 % and G1 or 2, and/or Ki-67 ≤ 20%, HER2 negative) or low risk if assessed by a validated genomic prognostic test (e.g. Mammaprint, Endopredict, Oncotype or...
- Distinct radiological sign of residual disease in the breast after neo-adjuvant chemotherapy by imaging
- Intra-/peritumoral microcalcifications larger than 2 cm at time of diagnosis
- Any local therapy (irradiation or surgery) to the currently treated breast prior to the trial intervention
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, trial intervention and follow-up...
The study team makes the final eligibility decision.
Where it's taking place
- Salzburg, Austria
- Schwaz, Austria
- Vienna, Austria
- Frankfurt, Germany
- Heidelberg, Germany
- Rostock, Germany
- Wuppertal, Germany
- Aarau, Switzerland
- Baden, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Chur, Switzerland
- Frauenfeld, Switzerland
- Genolier, Switzerland
- Lucerne, Switzerland
- Lugano, Switzerland
- Rheinfelden, Switzerland
- Sankt Gallen, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salzburg, Austria; Schwaz, Austria; Vienna, Austria; Frankfurt, Germany; Heidelberg, Germany; Rostock, Germany and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.